BTM · Class II · 21 CFR 868.5915

FDA Product Code BTM: Ventilator, Emergency, Manual (resuscitator)

Leading manufacturers include Ambu, Inc., Puritan Bennett Corp. and Medical Marketing Concepts.

210
Total
210
Cleared
123d
Avg days
1976
Since
Growing category - 3 submissions in the last 2 years vs 1 in the prior period
Consistent review times: 113d avg (recent)

FDA 510(k) Cleared Ventilator, Emergency, Manual (resuscitator) Devices (Product Code BTM)

210 devices
1–24 of 210
Cleared Oct 16, 2026
Disposable Manual Resuscitator (NPVC-001/RTMA
K263254
Xiamen Compower Medical Tech. Co., Ltd.
Anesthesiology · 29d
Cleared Nov 24, 2025
The BAG manual resuscitator and accessories
K251631
Laerdal Medical AS
Anesthesiology · 180d
Cleared Apr 25, 2025
butterflyBVM
K243861
Compact Medical, Inc.
Anesthesiology · 130d
Cleared Mar 18, 2023
EOlife®
K221841
Archeon
Anesthesiology · 267d
Cleared Aug 18, 2022
Sotair Device
K212905
Safe Bvm Corporation
Anesthesiology · 339d
Cleared Aug 26, 2021
Disposable Manual Resuscitator
K210288
Xiamen Compower Medical Tech. Co., Ltd.
Anesthesiology · 205d
Cleared Dec 07, 2018
Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20
K181583
Flexicare Medical Limited.
Anesthesiology · 175d
Cleared May 11, 2018
Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
K170663
Foremount Enterprise Co., Ltd.
Anesthesiology · 431d
Cleared Aug 29, 2016
Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator
K152931
Ambu A/S
Anesthesiology · 329d
Cleared Jan 15, 2015
NEONATALIE RESUSCITATOR
K132172
Laerdal Medical A/S
Anesthesiology · 549d
Cleared Jan 13, 2012
BABI PLUS NEONATAL RESUSCITATION BAG
K112852
A Plus Medical
Anesthesiology · 87d
Cleared Jan 28, 2011
AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC
K102824
Ambu A/S
Anesthesiology · 121d
Cleared Jan 06, 2011
NEOPOP INFANT RESUSCITATOR WITH FLOW METER
K102649
Neoforce Group, Inc.
Anesthesiology · 114d
Cleared Sep 17, 2010
REVIVATOR
K094003
Hersill, S.L.
Anesthesiology · 263d
Cleared Feb 05, 2010
POCKET BVM
K093081
Microbvm Systems , Ltd.
Anesthesiology · 127d
Cleared Oct 15, 2008
DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE
K082092
Galemed Corp.
Anesthesiology · 83d
Cleared Sep 12, 2008
SAVE RESUSCITATOR
K073410
Artivent Corporation
Anesthesiology · 283d
Cleared Jan 31, 2008
RESUSCITATION TIMER, MODEL L770-CPR
K073171
Allied Healthcare Products, Inc.
Anesthesiology · 83d
Cleared Sep 12, 2007
NEOPIP INFANT RESUSCITATOR
K072021
Neoforce Group, Inc.
Anesthesiology · 51d
Cleared Apr 20, 2007
GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM
K070247
Ohmeda Medical
Anesthesiology · 85d
Cleared Oct 18, 2006
RESUSCITATION TIMER, MODEL L770-CPR
K062080
Allied Healthcare Products, Inc.
Anesthesiology · 89d
Cleared Mar 22, 2006
HSINER RESUSCITATOR
K053466
Hsiner Co., Ltd.
Anesthesiology · 99d
Cleared Dec 23, 2005
AMBU MARK IV RESUSCITATOR
K053140
Ambu A/S
Anesthesiology · 44d
Cleared Dec 20, 2005
AMBU MARK IV BABY RESUSCITATOR
K053142
Ambu A/S
Anesthesiology · 41d

About Product Code BTM - Regulatory Context

510(k) Submission Activity

210 total 510(k) submissions under product code BTM since 1976, with 210 receiving FDA clearance (average review time: 123 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - BTM Product Code

FDA review times for BTM submissions have been consistent, averaging 113 days recently vs 123 days historically.

BTM devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →